Acute Ischemic StrokePhase 1/2TUCSONNCT00504842
Transcranial Ultrasound in Clinical SONothrombolysis
A Phase 1/2 study testing MRX-801 in people with Acute Ischemic Stroke, run by ImaRx Therapeutics at 14 sites in 2 countries.
Trial summary
This is a randomized, placebo controlled, parallel group dose escalation trial to evaluate the safety, tolerability, and activity of four sequential dose tiers of MRX-801 and ultrasound as an adjunctive therapy to tissue plasminogen activator (tPA) treatment in subjects with acute ischemic stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- MRX-801
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 14 sitesin 2 countries
- Study dates
- Dec 2006to Mar 2008
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute ischemic stroke
- Occlusion demonstrated by transcranial Doppler ultrasound
- Eligible for tPA
Who cannot join
- Right to left cardiac shunt
- Moderate to severe COPD
- Uncontrolled hypertension
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
United States13 sites
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103
University of Alabama
Birmingham, Alabama, 35249
Colorado Neurological Institute
Englewood, Colorado, 80113
Methodist Hospital Neurological Institute
Houston, Texas, 77030
University of Texas
Houston, Texas, 77030
University of Miami
Miami, Florida, 33136
Christiana Care Health System
Newark, Delaware, 19718
Hoag Memorial Hospital
Newport Beach, California, 92658
Barrow Neurology Clinics at St. Joseph's Hospital
Phoenix, Arizona, 85013
University of Rochester
Rochester, New York, 14642
California Pacific Medical Center
San Francisco, California, 94115
Swedish Medical Center
Seattle, Washington, 98122
St. Louis University School of Medicine
St Louis, Missouri, 63104
France1 site
Bichat - Claude Bernard University Hospital and Medical School
Paris
About this study
Official title: A Phase 1-2, Randomized, Placebo-Controlled, Single-Blind, Dose Escalation Study to Evaluate the Safety, Tolerability, and Activity of Ascending Single Doses of MRX-801 With Continuous Ultrasound Administration in Subjects With Acute Ischemic Stroke Receiving Treatment With Intravenous Tissue Plasminogen Activator
This is a randomized, placebo controlled, parallel group dose escalation trial to evaluate the safety, tolerability, and activity of four sequential dose tiers of MRX-801 and ultrasound as an adjunctive therapy to tissue plasminogen activator (tPA) treatment in subjects with acute ischemic stroke.
- Conditions
- Acute Ischemic Stroke
- Being tested
- MRX-801, Placebo
- Keywords
- Acute Ischemic Stroke, Microbubbles, Transcranial Doppler ultrasound, TIBI, Symptomatic Intracranial Hemorrhage, modified Rankin Scale, Recanalization, Perflutren
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRX-801Drug
PlaceboDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of symptomatic intracranial hemorrhage
Measured: 36 hours
Secondary outcomes (2)
Rate of recanalization of occluded artery
Measured: 120 minutes
Independent outcome (modified Rankin Scale 0-2)
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2007 (estimated)
- Study startDec 2006
- Study completionMar 2008
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ImaRx Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Carlos Molina Cateriano, MD, Study director, University Hospital Vall d'Hebron, Barcelona, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00504842
- Sponsor's protocol ID
- MRX-06-101-CP-01-01
- Acronym
- TUCSON
- Status last verified
- Apr 2008
- First submitted
- 18 Jul 2007
- Last updated
- 15 Apr 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1-2, Randomized, Placebo-Controlled, Single-Blind, Dose Escalation Study to Evaluate the Safety, Tolerability, and Activity of Ascending Single Doses of MRX-801 With Continuous Ultrasound Administration in Subjects With Acute Ischemic Stroke Receiving Treatment With Intravenous Tissue Plasminogen Activator
- ClinicalTrials.gov ID
- NCT00504842
- Acronym / sponsor ID
- TUCSON / MRX-06-101-CP-01-01
- Conditions
- Acute Ischemic Stroke
- Keywords
- Acute Ischemic Stroke, Microbubbles, Transcranial Doppler ultrasound, TIBI, Symptomatic Intracranial Hemorrhage, modified Rankin Scale, Recanalization, Perflutren
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- ImaRx TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Study completion
- Mar 2008 (actual)
- First posted
- 20 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, placebo controlled, parallel group dose escalation trial to evaluate the safety, tolerability, and activity of four sequential dose tiers of MRX-801 and ultrasound as an adjunctive therapy to tissue plasminogen activator (tPA) treatment in subjects with acute ischemic stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Acute ischemic stroke
- Occlusion demonstrated by transcranial Doppler ultrasound
- Eligible for tPA
Key exclusion criteria (3 listed)
- Right to left cardiac shunt
- Moderate to severe COPD
- Uncontrolled hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRX-801 | Drug | – |
| Placebo | Drug | – |
Primary outcome
Incidence of symptomatic intracranial hemorrhage
Time frame: 36 hours
2 secondary outcomes
Rate of recanalization of occluded artery
Time frame: 120 minutes
Independent outcome (modified Rankin Scale 0-2)
Time frame: 90 days
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos Molina Cateriano, MD study director
University Hospital Vall d'Hebron, Barcelona, Spain
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MRX-801 in people with Acute Ischemic Stroke, run by ImaRx Therapeutics at 14 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of symptomatic intracranial hemorrhage (time frame: 36 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2008.